a phase i, multicenter, clinical trial to evaluate the safety and immunogenicity of vaccinia-derived mn hiv-1 recombinant envelope glycoprotein (rgp160) of human immunodeficiency virus at two different vaccination schedules

Conditions: HIV Infections

Summary: to determine the safety and immunogenicity of 200 mcg mn rgp160 vaccine (immuno-ag) versus placebo, administered on two immunization schedules to healthy volunteers. per 06/15/94 amendment, to determine the safety and immunogenicity of 800 versus 200 mcg given as a fourth immunization at 9 or 11 months after the third injection (i.e., at month 17). a gp160 vaccine developed from the iiib strain of hiv-1 has been found to be safe and immunogenic in healthy adults. since the mn strain of hiv-1 is representative of a larger proportion of hiv-1 isolates in the united states than is the iiib strain, evaluation of a gp160 vaccine derived from the mn strain is important.

a gp160 vaccine developed from the iiib strain of hiv-1 has been found to be safe and immunogenic in healthy adults. since the mn strain of hiv-1 is representative of a larger proportion of hiv-1 isolates in the united states than is the iiib strain, evaluation of a gp160 vaccine derived from the mn strain is important. volunteers are randomized to receive 200 mcg mn rgp160 or placebo at months 0, 1, and 6 or at months 0, 2, and 8. for each immunization schedule, ten volunteers receive vaccine and two volunteers receive placebo. per amendment, volunteers receive a fourth immunization of 800 or 200 mcg (or placebo) at 9 or 11 months after the third injection (i.e., at month 17) and are followed for 6 months afterward.

Eligibility criteria:
inclusion criteria subjects must have: * normal history and physical exam. * negative test for hiv by elisa within 6 weeks prior to immunization. * cd4 count \>= 400 cells/mm3. * normal urine dipstick with esterase and nitrate. * no history of immunodeficiency, chronic illness, autoimmune disease, or use of immunosuppresssive medications. exclusion criteria co-existing condition: subjects with the following conditions are excluded: * positive for hepatitis b surface antigen. * medical or psychiatric condition or occupational responsibilities that preclude compliance. * active syphilis (note: if serology is documented to be a false positive or due to a remote (\> 6 months) infection, subject is eligible). * active tuberculosis (note: subjects with a positive ppd and normal x-ray showing no evidence of tb and who do not require inh therapy are eligible). subjects with the following prior conditions are excluded: * history of anaphylaxis or other serious adverse reactions to vaccines. prior medication: excluded: * prior hiv vaccines. * live attenuated vaccines within the past 60 days. note: medically indicated subunit or killed vaccines (e.g., influenza, pneumococcal) do not exclude but should be administered at least 2 weeks prior to hiv immunizations. * experimental agents within the past 30 days. prior treatment: excluded: * blood products or immunoglobulin within the past 6 months. higher risk behavior for hiv infection as determined by screening questionnaire, including: * history of injection drug use within 12 months prior to study entry. * higher or intermediate risk sexual behavior.

Keywords: vaccines, synthetic hiv-1 hiv envelope protein gp160 aids vaccines hiv seronegativity hiv preventive vaccine